A new analysis by the U.S. Food and Drug Administration reveals a comprehensive list of the most commonly-reported systemic symptoms in women with breast implants.
Other matters of interest to women with breast implants include the number and percent of women who reported either improvement or worsening in their systemic systems following explant surgery.
Here are several of the key takeaways from the FDA’s analysis of 15½ years of select medical device reports related to silicone and saline breast implants and systemic symptoms reported.
1. FDA Reviewed Medical Device Reports (MDRs) Spanning 15 Years, 5 Months
The U.S. FDA reviewed its medical device report, or MDR, database for all reports posted from January 1, 2008 to June 30, 2023, a period of 15 years and 5 months.
2. FDA Cautions Against Determining Prevalence, Causation, Based on MDRs
The FDA says the MDR system is a valuable source of information, but it cautions members of the public that the system is both passive and significantly limited. It also says the receipt of a report, such as those tabulated by the FDA and covered here, does not in itself establish or confirm that the device in question (breast implants in this case), either caused or contributed to the adverse event or symptom reported.
3. FDA Isolated MDRs Mentioning ‘BII,’ ‘Breast Implant Illness,’ and 90 Other Terms
The U.S. FDA analyzed all reports involving both saline or silicone-filled breast implants, whose descriptive data included the phrases “BII,” “Breast implant illness,” “Generalized/unexplained illness,” and “Unexplained systemic symptoms,” as well as 90 other terms, including “acid reflux,” “allergy,” “Lyme disease.” (A complete table of the 90 “search terms relevant to systemic symptoms referred to as BII” published by the FDA, is available here.)
4. FDA Analyzed 9,458 Reports in Total
The FDA identified a total of 9,458 MDRs that met its analysis criteria, above, and which were not known to be duplicate reports. The FDA excluded reports it was able to determine were duplicates.
5. Not All Reports Analyzed Included Key Tabulation Data
Though 9,458 medical device reports met the Agency’s overall criteria for inclusion in the analysis, some of the reports lacked enough information to be useful in all parts of the analysis. For instance, only 7,207, or 76 percent, of the 9,458 reports included enough data to determine when a patient’s systemic symptoms began, relative to when they received breast implants.
6. Patients Were 42.4 Years of Age on Average
Patients’ ages were noted in 58.8 percent of reports (5,569 out of 9,458). Patients whose age was known or discoverable ranged from 9-99-years-old, with 42.4 years of age being the average age at which women reported systemic symptoms believed to be caused by their breast implants.
(The U.S. regulatory agency also notes that it saw “several reports” concerning “children born to women with breast implants where the reporter believed the child’s symptoms or events to be attributable to the mother’s implants.”)
7. Systemic Symptom Onset Occurred an Average of 5.4 Years Post-Augmentation
For 76 percent of reports (7,207 out of 9,458), FDA analysts were able to determine the length of time between when breast implants were placed, and when systemic symptom onset occurred. “In these cases, the average time to onset was 5.4 years with a range of 0-42.5 years,” the FDA reports.
8. Top 10 Systemic Symptoms Included Fatigue, Joint Pain, Anxiety
Medical device reports analyzed by the FDA “sometimes” listed more than one symptom, the Agency says.
This table shows the “top 10 most frequent systemic-related search terms appearing in the 9,458 reports,” as analyzed by the U.S. Food and Drug Administration:
FDA: Table 1. Most Common Systemic Signs or Symptoms
| Symptom | Percent of MDRs Reporting Symptom* |
| Fatigue | 42.1 |
| Joint pain | 30.5 |
| Anxiety | 23 |
| Brain fog | 22.9 |
| Autoimmune diseases** | 21.1 |
| Hair Loss | 20.1 |
| Depression | 17.3 |
| Rash | 16.7 |
| Headache | 16.1 |
| Weight (loss, gain, other) | 15.5 |
This tabulation suggests that 42.1 percent of women with breast implants who also had systemic symptoms, and about whom medical device reports were filed, experienced fatigue; that 21.1 percent of medical device reports filed about women with breast implants and who also had systemic symptoms, mentioned autoimmune disease, or the symptoms or diagnosis of one.
Importantly, these percentages do not mean, for instance, that “42.1 percent of women with breast implants experience fatigue,” as the Agency’s analysis merely includes women with breast implants who also have systemic symptoms, and about whom MDRs were filed (during the above timeframes, and which met the Agency’s inclusion criteria, covered above.)
9. 40.8 Percent of Affected Women Explanted; Had Breast Implants Removed
Treatment for breast implant illness “involves implant removal,” the Cleveland Clinic says. Of the 9,458 MDRs analyzed by the FDA, 40.8 percent of reports (3,861), included the fact that the patient had their breast implants removed at some point after experiencing symptoms.
10. Women Explanted an Average of 8.9 Years Post-Augmentation
Of the MDRs that reported explant or breast implant removal, 3,664 included enough data to determine the length of time between a patient receiving breast implants (breast augmentation surgery, or “implantation”), and the date of explant or breast implant removal surgery. “The average time to explant was 8.9 years, with a range of 0-47 years,” the FDA reports.
11. 87.5% of Women Explanting Reported Symptom Improvement
Of the 9,458 medical device reports that met FDA inclusion criteria, 752 reports included information related to whether symptoms got better or worse following breast implant removal. 87.5 percent of reports noted improvement in systemic symptoms following explant, or breast implant removal, surgery.
“Only 752 reports provided information related to the status of a woman’s symptoms following explant. Of these, 658 [87.5%] noted improvement and 94 [12.5%] noted either no improvement or worsening of symptoms.”
U.S. FDA, “Medical Device Reports for Systemic Symptoms in Women with Breast Implants,” Dec. 15, 2023. [Percentages added in brackets.]
12. 12.5% of Women Explanting Reported No Improvement, or a Worsening of Symptoms
Ninety-four reports noted either no improvement, or a worsening of symptoms following breast implant removal surgery.
The FDA’s analysis covers 15.5 years worth of medical device reports that met inclusion criteria.
It was released December 15, 2023. View the FDA’s report, “Medical Device Reports for Systemic Symptoms in Women with Breast Implants” at FDA.GOV.
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